Earlier this year, Johnson & Johnson (J&J) announced the completion of the acquisition of Actelion for a purchase price of about $30 billion in cash. Actelion will now become part of the Janssen Pharmaceutical Companies of J&J. Prior to the acquisition, Actelion had been competing with United Therapeutics to lead the pulmonary arterial hypertension (PAH) market.  Upon acquiring Actelion, J&J has firmly cemented itself as the clear leader in the PAH market.

PAH is a rare, fatal cardiopulmonary disease characterized by an abnormal rise in the resting mean pulmonary artery pressure (PAP) (>25mmHg, compared with normal levels around 14mmHg), a pulmonary vascular resistance of more than three Wood units, and a pulmonary capillary wedge pressure less than 15mmHg. This increased PAP is caused by pulmonary arterial obstruction due to endothelial dysfunction and vascular remodeling, and leads to increased resistance in the arterial blood vessels. Since PAH is a progressive disorder, the pulmonary pressure keeps building up as the patient advances through the later stages of the disease, leading to reduced cardiac output, right heart failure, and ultimately death. PAH is a subset (Group 1) within the WHO’s classification of the different types of pulmonary hypertension (PH).

The approaches to PAH pharmaceutical treatment can be classified broadly into two types: those that inhibit vasoconstriction (narrowing of blood vessels) and those that enhance vasodilation (widening of blood vessels). The currently marketed drugs address the deficiencies that accompany impaired secretion of vasodilators such as nitric oxide (NO) and prostacyclin (PGI2), or correct the prolonged over expression of vasoconstrictors such as endothelin. The five classes of marketed drugs are endothelin receptor antagonists (ERAs), phosphodiesterase type 5 (PDE5) inhibitors, soluble guanylate cyclase (sGC) stimulators, prostacyclin derivatives, and prostacyclin IP receptor agonists.

Actelion has developed five of the 13 marketed branded drugs indicated for the treatment of PAH, including two ERAs, two prostacyclin derivatives, and one prostacyclin IP receptor agonist. Actelion’s Tracleer (bosentan) used to be the standard of care (SOC) ERA therapy for PAH patients, prior to the launches of GSK’s Volibris (ambrisentan; marketed in Europe and Japan), Gilead’s Letairis (also ambrisentan; marketed only in the US), and Actelion’s Opsumit (macitentan). According to Key Opinion Leaders (KOLs) interviewed by GlobalData, macitentan is prescribed more than ambrisentan,as the former has fewer side effects and reimbursement issues, demonstrating Actelion’s continued dominance  of the ERA market.

PAH treatment with prostacyclin derivativesis where Actelion has seen the most competition. Actelion’sVeletri (epoprostenol) and Ventavis (iloprost) are administered intravenously and via inhalation, respectively. However, to increase patient compliance and reduce the burden of therapy, United Therapeutics launched Remodulin (treprostinil), Tyvaso (treprostinil), and Orenitram (treprostinil), which are administered subcutaneously, via inhalation, and orally, respectively. In response to United’s strong treprostinil portfolio, Actelion launched its first-in-class oral selective prostacyclin IP receptor agonist, Uptravi (selexipag), in 2016. According to KOLs interviewed by GlobalData, physicians prefer Selexipag to Orenitram (oral treprostinil) because of its increased tolerability and efficacy.

Historically, Actelion has been a stronghold in the PAH drug market, and as such, J&J should not experience any significant issues in the near future regarding strong competition from  other PAH drug companies. For the past six years, J&J has brought in the most revenue of all pharmaceutical companies. Although Actelion does not currently have any PAH drugs in the pipeline, J&J has an abundance of resources to continue Actelion’s legacy of dominating the PAH market. Unless competitors can launch efficacious drugs with favorable administration, J&J will be a leader in the PAH market for years to come.

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